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Effect of Rosuvastatin and Eicosapentaenoic Acid on Neoatherosclerosis: The LINK-IT Trial

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ClinicalTrials.gov Identifier: NCT03192579
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Hiromasa Otake, Kobe University

Brief Summary:
This study aim to evaluate whether intensive lipid lowering therapy may improve the clinical outcomes in coronary artery disease patients with in-stent neoatherosclerosis, in comparison with standard therapy.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Progression Drug: EPA and high dose rosuvastatin Drug: Standard dose rosuvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Consecutive patients with stent implantation who were performed coronary angiography and OCT follow-up of the coronary arteries were screened. The patients with neoatherosclerosis were randomly assigned to either 2.5-5mg/day of rosuvastatin therapy or 10mg/day(up to 20mg) of rosuvastatin and 1800mg/day of eicosapentaenoic acid therapy at a 1:1 ratio for 12 months.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Rosuvastatin and Eicosapentaenoic Acid on Neoatherosclerosis: The LINK-IT Trial
Actual Study Start Date : July 26, 2013
Actual Primary Completion Date : June 2, 2017
Actual Study Completion Date : June 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standard lipid lowering therapy
Start with only rosuvastatin 2.5mg and up to 20mg/day
Drug: Standard dose rosuvastatin
After randomization, patients with standard lipid lowering therapy start only rosuvastatin (2.5mg/day) for 12 months.
Other Name: rosuvastatin

Active Comparator: Intensive lipid lowering therapy
Start EPA and rosuvastatin 10mg/day and up to 20mg/day
Drug: EPA and high dose rosuvastatin
After randomization, patients with intensive lipid lowering therapy start EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for 12 months.
Other Names:
  • Rosuvastatin
  • Eicosapentaenoic acid




Primary Outcome Measures :
  1. Lipid index change between baseline and 12 month follow-up [ Time Frame: Baseline and 12 month follow-up ]
    Lipid core arc was measured by every 0.2-mm interval throughout segments with NA on OCT findings. The mean lipid core arc was calculated for each lesion. Then, the lipid index was calculated by multiplying the mean lipid core arc by the lipid core longitudinal length.


Secondary Outcome Measures :
  1. Macrophage grade change between baseline and 12 month follow-up [ Time Frame: Baseline and 12 month follow-up ]
    Macrophage arc were measured on OCT images with NA every 0.2-mm intervals and divided 4 groups as follows: grade 0, no mac¬rophage; grade 1, localized macrophage accumulation (<30°); grade 2, clus¬tered accumulation ≥30° and <90°; grade 3, clus¬tered accumulation ≥90° and <270°; and grade 4, clustered accumulation ≥270° and <360° . Macrophage grade was evaluated as summation of 0 to 4 grades across all cross section in NA.



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive patients with stent implantation who were performed coronary angiography and OCT follow-up of the coronary arteries were candidate. During this period, OCT was performed for the following reasons: 1) planned follow-up coronary angiography and OCT for routine stent follow-up or due to other study protocols, regardless of symptoms; 2) evidence of myocardial ischemia such as silent myocardial ischemia, stable angina, or acute coronary syndrome; or 3) planned follow-up angiography for other stent segments. These patients were implanted bare metal stent, sirolimus-eluting stents (Cypher, Cordis, Miami Lakes, FL, USA), paclitaxel-eluting stents (Taxus, Boston Scientific, Natick, MA, USA), or everolimus-eluting stents (XIENCE V, Abbott Vascular, Santa Clara, CA, USA). The investigators assessed their OCT examination at the follow-up OCT time and patients who were detected NA on OCT findings were eligible for the presence study.

Exclusion Criteria:

  • Exclusion criteria for OCT were 1) anatomically unsuitable target artery for OCT according to previously described criteria, 10 2) apparent congestive heart failure, 3) renal insufficiency with baseline creatinine level ≥2.0 mg/dL expect for under hemodialysis, or 4) lack of written informed consent from the patient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192579


Sponsors and Collaborators
Kobe University
Investigators
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Study Chair: Hiromasa Otake, ph.D Kobe University Graduate School of Medicine

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Responsible Party: Hiromasa Otake, Kobe University Graduate School of Medicine, Kobe University
ClinicalTrials.gov Identifier: NCT03192579     History of Changes
Other Study ID Numbers: KobeU
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hiromasa Otake, Kobe University:
neoatherosclerosis

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Disease Progression
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
Pathologic Processes
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors